Fast Track Designation Sample Clauses

Fast Track Designation. In addition to the foregoing, a separate process for Tier 3 designation shall operate during the second and third years of this Agreement. During the 2019-20 and 2020-21 academic years, Adjunct Faculty awarded Tier 2 status during the first year or second year of this Agreement who also have at least 10 years of service (with at least 5 years with an annual teaching load of more than 50%) with at least two class observations (at least one administrative) and 12 courses of student evaluations shall be eligible to apply for Tier 3 status.
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Fast Track Designation. In a November 4th press release, Lipocine shared its success in obtaining the FDA’s Fast Track Designation for LPCN 1144 for treatment of non-cirrhotic XXXX. The designation is requested by a sponsor company for drug can- didates that treat serious conditions and fill an unmet medical need. As no other XXXX treatments have been ap- proved and results from the LiFT trial were positive, the designation is welcome and not a surprise. The status should help Lipocine more efficiently design the Phase III program with closer guidance by the regulatory agency. It will also confer several benefits including more frequent interaction with the FDA, eligibility for accelerated approval, priority review and rolling review. Rolling review will allow Lipocine to submit portions of its new drug application (NDA) as they become ready rather than waiting until the entire package is ready thereby speeding the review pro- cess. January 2021 Topline Results from LiFT Study Lipocine announced positive 12-week topline data from its LiFT study in January 2021. LiFT is a Phase II evalua- tion of its candidate LPCN 1144, an oral pro-drug of endogenous testosterone, in biopsy-confirmed, non-cirrhotic male XXXX patients with F1-F3 fibrosis. Results were positive and show statistical significance in the primary end- point of change in hepatic fat fraction, quantified via MRI-PDFF1 at week 12. Lipocine’s LPCN 1144 demonstrated robust, statistically significant efficacy in not only its primary endpoint of reduction of hepatic fat fraction, but also secondary endpoints that were published in August.
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Related to Fast Track Designation

  • Filing Designation The City Department Director will designate each individual who will be providing services to the City pursuant to the Agreement as full disclosure, limited disclosure, or excluded from disclosure, based on an analysis of the services the Consultant will provide. Notwithstanding this designation or anything in the Agreement, the Consultant is ultimately responsible for complying with FPPC regulations and filing requirements. If you have any questions regarding filing requirements, please do not hesitate to contact the City Clerk at (000)000-0000, or the FPPC at 0-000-XXX-XXXX, or (000) 000-0000 *2. Pursuant to the duly adopted City of Chula Vista Conflict of Interest Code, this document shall serve as the written determination of the consultant’s requirement to comply with the disclosure requirements set forth in the Code.

  • Website Incorporation The State is not bound by any content on Contractor’s website unless expressly incorporated directly into this Contract.

  • Timber Designations Timber designated for cutting shall be confined to Sale Area, except as provided in B2.131, B2.14, B2.15, B2.32, and B5.1. Sale Area Map indicates subdivisions, if any, where Marking under B2.35 is to be done after timber sale advertisement, except for construction clearing under B2.32, minor changes under B2.37, and damaged timber. The boundaries of Clearcutting Units, Overstory Re- moval Units, and Understory Removal Units were plainly Marked on ground before timber sale advertisement and are shown on Sale Area Map. Boundary trees shall not be cut. The number of units and approximate acreage of timber designations are stated in A3.

  • Unbundled Copper Loop – Designed (UCL-D) 2.4.2.1 The UCL-D will be provisioned as a dry copper twisted pair (2- or 4-wire) Loop that is unencumbered by any intervening equipment (e.g., filters, load coils, range extenders, digital loop carrier, or repeaters).

  • Written Designation The Owner shall designate, in writing, a representative authorized to act on the Owner's behalf with respect to the Project. The Owner hereby designates the party identified in the Contract as its initial authorized representative and reserves the right to designate additional or replacement representatives by written notice to the Contractor.

  • Unbundled Copper Loop – Non-Designed (UCL-ND 2.4.3.1 The UCL–ND is provisioned as a dedicated 2-wire metallic transmission facility from BellSouth’s Main Distribution Frame (MDF) to a customer’s premises (including the NID). The UCL-ND will be a “dry copper” facility in that it will not have any intervening equipment such as load coils, repeaters, or digital access main lines (DAMLs), and may have up to 6,000 feet of bridged tap between the End User’s premises and the serving wire center. The UCL-ND typically will be 1300 Ohms resistance and in most cases will not exceed 18,000 feet in length, although the UCL-ND will not have a specific length limitation. For Loops less than 18,000 feet and with less than 1300 Ohms resistance, the Loop will provide a voice grade transmission channel suitable for Loop start signaling and the transport of analog voice grade signals. The UCL-ND will not be designed and will not be provisioned with either a DLR or a test point.

  • Termination of Designation of Convalescent Care Beds (a) Notwithstanding section 6.3, the provisions in this section 6.5 apply to the termination of a designation of convalescent care Beds.

  • TIME OFF FOR VOTING (a) If an employee does not have sufficient time outside of working hours to vote at a statewide election, the employee may, without loss of pay, take off enough working time that, when added to the voting time available outside of working hours, will enable the employee to vote.

  • Creation and Designation There is hereby created a Tranche of Class A Notes to be issued pursuant to this Terms Document, the Indenture and the Indenture Supplement to be known as the “DiscoverSeries Class A(2018-6) Notes.”

  • Voting Certificates and Block Voting Instructions Each Paying Agent shall, at the request of the Holder of any Bearer Note held in a clearing system, issue Voting Certificates and Block Voting Instructions in a form and manner which comply with the provisions of Schedule 2 (Provisions for Meetings of Noteholders) (except that it shall not be required to issue the same less than forty-eight hours before the time fixed for any Meeting therein provided for) and shall perform and comply with the provisions of Schedule 2 (Provisions for Meetings of Noteholders). Each Paying Agent shall keep a full record of Voting Certificates and Block Voting Instructions issued by it and will give to the Issuer not less than twenty-four hours before the time appointed for any Meeting or adjourned Meeting full particulars of all Voting Certificates and Block Voting Instructions issued by it in respect of such meeting or adjourned Meeting.

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